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Artificial Intelligence for Diminutive Polyp Characterization

NCT05391477 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2023-05-31

No results posted yet for this study

Summary

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

Conditions

  • Colorectal Neoplasms

Interventions

DEVICE

GI-Genius artificial intelligence

The software allows for the real-time characterization of framed polyps during a colonoscopy classifying them on adenoma or non-adenoma.

Sponsors & Collaborators

  • European Society of Gastrointestinal Endoscopy

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Hospital Universitario La Fe

    lead OTHER

Principal Investigators

  • Marco Bustamante Balén, M.D., Ph.D. · Hospital Universitario La Fe

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391477 on ClinicalTrials.gov